Phases of Drug Development and Drug Development Paradigms

In this chapter, the authors review the stages of modern drug development, evaluate past, current and potentially future paradigms aimed at streamlining the process and review tools such as the target product profile (TPP) and integrated product development plan (IPDP) used by sponsors to outline and refine their development programs. Both the TPP and IPDP are critical to the planning efforts that pharmaceutical companies engage in while developing new chemical entities in pursuit of market access. There are many schematics that organize the product stages in a sequential manner illustrating the duration of the individual phase and occasionally the cost, usually on a chronologic scale that illustrates the cumulative time in development. Many opinions exist on how the current drug development paradigm can be modified to reduce the time and cost of development.